Application 201005

Type: ANDA
Sponsor: AKORN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DESOXIMETASONE	DESOXIMETASONE	OINTMENT;TOPICAL	0.25%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201005-001	DESOXIMETASONE	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB		2014-04-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A201005-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201005-001	DESOXIMETASONE	0.25%	OINTMENT / TOPICAL	AB	2014-04-24	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A201005-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A201005-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201005-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201005-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201005-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201005-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201005-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201005-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201005-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201005-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201005-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201005-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201005-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201005-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201005-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201005-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201005-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201005-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201005-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201005-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201005-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201005-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201005-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201005-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201005-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201005-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201005-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201005-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201005-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201005-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201005-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201005-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201005-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201005-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201005-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201005-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201005-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201005-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201005-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201005-001	AB	1	`f41ea6bd6efb…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
desoximetasone	DESOXIMETASONE	Zydus Lifesciences Limited	959e396a-2458-43b5-b412-db1974d58d8d	2024-08-14		Name fallback brand name: desoximetasone generic name: DESOXIMETASONE
desoximetasone	DESOXIMETASONE	Bryant Ranch Prepack	155e0a5f-183b-4517-88e3-22fef48d72c8	2024-05-31	Warnings, Adverse reactions	Name fallback brand name: desoximetasone generic name: DESOXIMETASONE
desoximetasone	DESOXIMETASONE	Bryant Ranch Prepack	23b53d98-71fe-4e64-b546-9d7c8ec21a6c	2024-04-04	Warnings, Adverse reactions	Name fallback brand name: desoximetasone generic name: DESOXIMETASONE
desoximetasone	DESOXIMETASONE	Bryant Ranch Prepack	2a59a313-efd8-4377-bd41-caeeffa79775	2024-03-12	Warnings, Adverse reactions	Name fallback brand name: desoximetasone generic name: DESOXIMETASONE
Desoximetasone	DESOXIMETASONE	A-S Medication Solutions	0e72952e-8e9f-467a-8191-2bc157087d60	2023-12-09	Warnings, Adverse reactions	Name fallback brand name: Desoximetasone generic name: DESOXIMETASONE
desoximetasone	DESOXIMETASONE	Padagis Israel Pharmaceuticals Ltd	dc104fb8-4d7c-4bed-b2d8-8d9cfe8f0e5b	2023-08-31	Warnings, Adverse reactions	Name fallback brand name: desoximetasone generic name: DESOXIMETASONE
desoximetasone	DESOXIMETASONE	Bryant Ranch Prepack	dbaa172e-2f78-4c14-9abc-cc171b75115d	2023-07-17	Warnings, Adverse reactions	Name fallback brand name: desoximetasone generic name: DESOXIMETASONE
desoximetasone	DESOXIMETASONE	Padagis Israel Pharmaceuticals Ltd	4025ed23-a591-4754-8dbb-4da18f49a3e3	2022-12-02	Warnings, Adverse reactions	Name fallback brand name: desoximetasone generic name: DESOXIMETASONE
desoximetasone	DESOXIMETASONE	Viona Pharmaceuticals Inc	f8e213a9-5e80-45e2-834c-7734dd39c1ac	2022-10-04	Warnings, Adverse reactions	Name fallback brand name: desoximetasone generic name: DESOXIMETASONE
desoximetasone	DESOXIMETASONE	Viona Pharmaceuticals Inc	309a93de-ce89-4244-959a-3236d5e95c06	2022-10-04	Warnings, Adverse reactions	Name fallback brand name: desoximetasone generic name: DESOXIMETASONE
Desoximetasone	DESOXIMETASONE	Proficient Rx LP	f30b6fcc-43bc-4d65-9c3b-8d6ca780a024	2022-04-01	Warnings, Adverse reactions	Name fallback brand name: Desoximetasone generic name: DESOXIMETASONE
Desoximetasone	DESOXIMETASONE	Proficient Rx LP	4f90b0cd-9443-4940-8781-1a05e42ccbb8	2020-06-01	Warnings, Adverse reactions	Name fallback brand name: Desoximetasone generic name: DESOXIMETASONE
Desoximetasone	DESOXIMETASONE	Actavis Pharma, Inc.	c342beac-547b-4b0b-a39c-44a0961f924b	2020-01-01	Warnings, Adverse reactions	Name fallback brand name: Desoximetasone generic name: DESOXIMETASONE
Desoximetasone	DESOXIMETASONE	Glenmark Pharmaceuticals Inc., USA	ea742af6-9359-46c3-9164-ab53e8c1461e	2018-12-11	Warnings, Adverse reactions	Name fallback brand name: Desoximetasone generic name: DESOXIMETASONE
Desoximetasone	DESOXIMETASONE	Novel Laboratories, Inc.	781a7bba-b00d-4ceb-aefe-74c73d263b67	2016-06-01	Warnings, Adverse reactions	Name fallback brand name: Desoximetasone generic name: DESOXIMETASONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61748-206	Desoximetasone	Desoximetasone	VersaPharm Incorporated	ANDA	Current
61748-206	Desoximetasone	Desoximetasone	VersaPharm Incorporated	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32076	ORIG	2014-04-25